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Anxiety disorders are the most common mental illness in the US, affecting approximately 40 million adults each year, and despite the abundance of antianxiety medications available, treatment resistance occurs in roughly 30% of patients. Anxiety disorders have a significant economic impact on the US healthcare system, costing between $42.3 billion and $46.6 billion annually, meaning it's essential to find alternative treatment options. Luckily, new research reveals that psychedelics may be the answer. Clinical trial results show that psilocybin, a potent psychedelic, has antidepressant effects in patients with depression and is more effective than escitalopram. Of course, this is just one of many successful studies involving the use of psychedelics as a treatment for mental illness. Companies like Cybin Inc (NYSE:CYBN) (NEO:CYBN), Seelos Therapeutics (NASDAQ:SEEL), Mind Medicine (MindMed) Inc (NASDAQ:MNMD) (NEO:MMED), Compass Pathways (NASDAQ:CMPS) and Mydecine Innovations Group Inc (NEO:MYCO) (OTCPK:MYCOF) are also focused on developing psychedelic-based treatments to combat the mental health crisis.
Cybin Inc (NYSE:CYBN) (NEO:CYBN) is focused on advancing psychedelics into therapeutics by designing proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.
On April 13, Cybin announced positive CYB004 preclinical data from a pharmacokinetic study evaluating its proprietary deuterated dimethyltryptamine (DMT) molecule, CYB004, administered by inhalation. Specifically, inhaled CYB004 showed significant advantages over intravenous and inhaled DMT, including longer duration of action and improved bioavailability. The study also demonstrated that inhaled CYB004 had a similar onset of effect and dose profile to IV DMT. These data may support the potential of inhalation as a viable and well-controlled delivery system for therapeutic psychedelics. Cybin is currently developing CYB004 for the treatment of anxiety disorders. The company expects to file a regulatory filing for a pilot study in the second quarter of 2022 and to initiate the pilot study in the third quarter.
"In many studies, DMT has shown to be a promising and effective psychedelic for the treatment of mental health issues. However, known side effects like disorientation and anxiety and its mode of administration have historically hindered its use and availability. CYB004 via inhalation may solve for these challenges and finally support a clinical path forward for this important therapeutic. As part of Cybin's overall mission to create safe and effective psychedelic-based therapeutics, inhaled CYB004 is being developed to potentially overcome the limitations of IV DMT and become an important treatment option for anxiety disorders for patients and physicians," said Doug Drysdale, Cybin's CEO.
On April 8, Cybin announced the publication of an international patent application covering inhalation delivery methods for multiple psychedelic molecules, further reinforcing Cybin's intellectual property (IP) position. The PCT application will allow Cybin to seek IP protection for multiple inhaled forms of psychedelic molecules that are currently being researched and developed by the company as well as other psychedelic molecules that may be developed in the future.
"The publication of this PCT patent application demonstrates our continued commitment to discovering and developing new psychedelic-based treatment options, in addition to identifying and combining potentially improved and well-controlled delivery systems with these clinical candidates," said Doug Drysdale. "In addition, our progress to secure IP for unique psychedelic delivery methods strongly aligns and supports our current CYB004 pipeline program of deuterated DMT via inhalation, which is aimed at overcoming some of the known challenges of oral and IV-administered DMT."
Cybin announced on March 31 that its sponsored feasibility study using Kernel Flow technology had conducted its first study visit. The main objective of the study is to evaluate a participant's experience wearing Kernel Flow while in an altered state of consciousness following the administration of ketamine. Participants will receive either a low dose of ketamine or placebo while wearing the Flow headset, which is equipped with hi-tech sensors to record brain activity and will report their experience using structured questionnaires and validated assessments during study visits and at follow-up. The four-week study will also evaluate brain activity before and after administering the study agents - low-dose ketamine or placebo.
For more information about Cybin Inc (NYSE:CYBN) (NEO:CYBN), click here.
Health Companies Are Developing Innovative Mental Health Treatments
Seelos Therapeutics (NASDAQ:SEEL), a clinical-stage biopharmaceutical company
focused on developing therapies for central nervous system disorders and rare diseases, reported on March 7 its 2021 end of year business and clinical update. Seelos began additional in vivo studies with its gene therapy focused on Parkinson's disease SLS-004 program after demonstrating its ability to reduce the expression of alpha-synuclein. The company has received an acknowledgment letter of a Clinical Trial Notification (CTN) from the Australian Department of Therapeutic Health Products Administration Goods Administration (TGA) for a pilot study of SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion) to treat patients with Alzheimer's disease. In addition, Seelos has received permission to conduct a separate open-label basket study in Australia to assess the efficacy, safety, and tolerability of SLS-005 on disease progression and severity in participants with certain neurodegenerative diseases, including Huntington's disease.
On March 28, Mind Medicine (MindMed) Inc (NASDAQ:MNMD) (NEO:MMED), a clinical-stage biopharmaceutical company developing new products to treat brain health disorders, announced its financial results for the fiscal year ended December 31, 2021. MindMed has initiated a program to develop a new treatment for the core symptoms of autism spectrum disorder. In February 2021, the company completed the acquisition of HealthMode and fully integrated its team to enable the fast progression of digital medicine and business operations functions. MindMed expects 2022 to be a transformational year in which it will continue to drive substantial growth in its pharmaceutical and digital drug pipelines.
COMPASS Pathways (NASDAQ:CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, has formed a long-term strategic partnership to launch The Centre for Mental Health Research and Innovation in the UK. In collaboration with South London and Maudsley NHS Foundation Trust (SLaM), the UK's largest National Health Service (NHS) mental health trust, and the Institute of psychiatry, Psychology & Neuroscience (IoPPN) at King's College London, this pioneering collaboration will provide patients with access to cutting-edge research studies in multiple areas of high unmet mental health need. The Centre will accelerate research into emerging psychedelic therapies, support the training and certification of therapists, assess real-world evidence, and prototype digital technologies to enable personalized, predictive, and preventative models of care.
Mydecine Innovations Group Inc (NEO:MYCO) (OTC:MYCOF) (FSA:ONFA) a biotechnology company aiming to transform the treatment of mental health disorders and addictions, has received conditional approval from the Institutional Review Board (IRB) for its multi-site Phase 2b smoking cessation trial pending FDA approval of its investigational new drug application (IND). Johns Hopkins University will serve as the primary research site. Mydecine expects to submit the IND application in the second quarter of 2022 and expects it to become effective 30 days after submission.
Cybin Inc (NYSE:CYBN) (NEO:CYBN) CEO Doug Drysdale presented at the 2022 Maxim Group Virtual Growth Conference on March 28-30 and will also present at the upcoming Benzinga Psychedelics Capital Conference on April 19.
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